Balance Calibration Weight 10 g (CAL-0333) – Calibration Documents

Calibration Documents: Balance Calibration Weight 10 g (CAL-0333)

Asset ID CAL-0333
Equipment Balance Calibration Weight 10 g
Equipment Type Standard Weight
Department Calibration Lab
Area/Location Metrology
Process Use Mass standard
Parameter Weight
Units g
Range Min 10
Range Max 10
Acceptance Criteria Class F1/E2
Calibration Frequency (days) 365
Calibration Type External
Traceability ISO17025

Table of Contents

  1. Calibration SOP
  2. Calibration Protocol
  3. Calibration Checklist
  4. Deviation Impact Assessment
  5. Calibration Certificate

Calibration SOP

1. Purpose

The calibration of the Balance Calibration Weight 10 g is performed to ensure the accuracy of mass measurements, which is critical for maintaining patient safety, ensuring batch quality, and preserving data integrity. Accurate weight measurements are essential in pharmaceutical processes to prevent dosage errors and ensure compliance with regulatory standards.

2. Scope

  • Asset ID: CAL-0333
  • Equipment Name/Type: Balance Calibration Weight 10 g / Standard Weight
  • Department/Area: Calibration Lab / Metrology
  • Process Use: Mass standard
  • Parameter: Weight
  • Range: 10 g
  • Units: g
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement standard to a known reference to determine accuracy.
  • Verification: The process of confirming that a measurement system is functioning correctly.
  • Adjustment: The process of modifying a measurement system to bring it into compliance with standards.
  • As Found: The condition of the equipment prior to any adjustments.
  • As Left: The condition of the equipment after adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement falls outside the specified acceptance criteria.
  • Drift: The gradual change in a measurement system’s performance over time.
  • Traceability: The ability to verify the history, location, or application of an item by means of documented recorded identification.
  • Measurement Uncertainty: A parameter that characterizes the dispersion of the values attributed to a measured quantity.
  • Intermediate Check: A verification process conducted between calibrations to ensure ongoing accuracy.

4. References

  • Company Metrology SOP [TBD]
  • ISO/IEC 17025 traceability via calibration certificates
  • ALCOA+ principles

5. Responsibilities

  • Technician/Metrology: Perform calibration and maintain records.
  • QC/QA Reviewer: Review calibration results and documentation.
  • Owner Department: Ensure equipment is available and in good condition for calibration.
  • External Service Provider: Conduct external calibration as required.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow equipment to warm up and stabilize before calibration.
  • Maintain cleanliness of the calibration area and equipment.
  • Check that the equipment is level before use.
  • Verify power supply is stable and functioning.
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7. Standards & Tools

  • Reference Standards Required: Calibration weights certified to ISO17025.
  • Traceability Statement: Calibration is traceable to ISO17025.
  • Certificate Validity Check: Ensure calibration certificates are current and valid.
  • Standard ID: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and As Left logic. The minimum number of points for calibration will be five, including endpoints and midpoints. It is recommended to take three replicate readings at each point to ensure accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the balance to stabilize in the calibration environment.
  3. As Found Checks and Data Capture: Measure the weight and record observations contemporaneously.
  4. Adjustment Rules: If OOT is detected, escalate for further evaluation; adjustments are only made if permitted.
  5. As Left Verification: Re-measure to confirm that the equipment is within tolerance after any adjustments.
  6. Labeling + Documentation Completion: Complete all required documentation and label the equipment accordingly.

10. Acceptance Criteria & Calculations

The acceptance criteria for this calibration are Class F1/E2. The error calculation formula is:

Error (%) = (Observed Value – True Value) / True Value × 100

Pass/Fail Logic: If the error falls within the acceptance criteria, the calibration passes; otherwise, it fails.

Rounding Rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag the equipment and cease use.
  • Notification & deviation initiation: Notify relevant personnel of the OOT condition.
  • Impact assessment trigger: Define the impact window and review affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries must be maintained for all calibration activities.
  • Calibration report/certificate filing must be completed and stored securely.
  • E-records if applicable: [TBD]
  • Label content requirements: calibrated date, due date, by whom, status.

13. Annexures

Annexure A: Calibration Data Sheet table (test points, ref, observed, error, acceptance, pass/fail; include As Found + As Left columns)

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Annexure B: Quick checklist

Annexure C: Example label text (with [TBD] placeholders)

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Calibration Protocol

Calibration Protocol

Protocol ID Asset ID Equipment Name Equipment Type Dept Area Process Use Parameter Units Range Acceptance Criteria Frequency Calibration Type Traceability
[TBD] CAL-0333 Balance Calibration Weight 10 g Standard Weight Calibration Lab Metrology Mass standard Weight g 10 – 10 Class F1/E2 365 days External ISO17025

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 10 g
  • 25%: 10 g
  • 50%: 10 g
  • 75%: 10 g
  • Maximum: 10 g

Results Table


Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
10 g 10 g [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the calibration weight is clean and free from contaminants.
  2. Stabilization: Allow the equipment to stabilize in the environmental conditions specified.
  3. Performing Readings: Take at least three replicate measurements at each test point.
  4. Calculating Error: Calculate the error for each observed value against the reference value.
  5. Evaluation: Compare the calculated errors against acceptance criteria.
  6. Documentation: Record all observations in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

  • Stop use of the equipment immediately.
  • Notify the QA department.
  • Open a deviation report.
  • Quarantine impacted results window: [TBD]
  • Await QA decision on further actions.

Approvals

Prepared Reviewed Approved
[Signature/Date] [Signature/Date] [Signature/Date]

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Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0333 Balance Calibration Weight 10 g Calibration Lab Metrology Weight 10 g Class F1/E2 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up for the specified duration
  • [ ] Clean the calibration weight and surrounding area
  • [ ] Level the balance if applicable
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for documentation

As Found Execution

  • [ ] Set the calibration weight to specified setpoints
  • [ ] Perform repeat measurements as per protocol
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for analysis

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment immediately
  • [ ] Notify relevant personnel
  • [ ] Document deviation from acceptance criteria
  • [ ] Trigger impact review as necessary

As Left Verification

  • [ ] Conduct post-adjustment checks
  • [ ] Confirm all measurements are within specified limits

Documentation & Closure

  • [ ] Update calibration label
  • [ ] Attach calibration certificate
  • [ ] Obtain reviewer sign-off
  • [ ] Update next due date in logbook

Data Integrity (ALCOA+): Ensure all data is attributable, legible, contemporaneous, original, and accurate.

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Deviation Impact Assessment

Event Summary Details
Asset Balance Calibration Weight 10 g
Date [TBD]
Discovered By [TBD]
Document References [TBD]
As Found Results Summary [TBD]

Immediate Containment Checklist

  • Stop use of the asset
  • Label/tag the asset as out of tolerance
  • Segregate impacted work

Define Impact Window

Last Known In-Tolerance Date Discovery Date
[TBD] [TBD]

Product/Batch/Test Impact Review

Batch/Study/Report ID Results Potentially Impacted Re-test/Re-weigh Decision
[TBD] [TBD] [TBD]

Data Integrity Review Prompts (ALCOA+)

  • Attributable: [TBD]
  • Legible: [TBD]
  • Contemporaneous: [TBD]
  • Original: [TBD]
  • Accurate: [TBD]
  • Complete: [TBD]
  • Consistent: [TBD]
  • Enduring: [TBD]
  • Available: [TBD]

Risk Assessment

Severity Probability Detectability Rationale Overall Risk
[TBD] [TBD] [TBD] [TBD] [TBD]

Investigation Summary

Root Cause: [TBD]

CAPA Plan

Action Owner Due Date Effectiveness Check
[TBD] [TBD] [TBD] [TBD]

QA Disposition

Release/Hold/Retest/Recall Triggers: [TBD]

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Calibration Certificate

Certificate No: [TBD]

Date: [TBD]

Next Due Date: [TBD]

Asset Details

Asset ID Equipment Name Equipment Type Dept Area Make/Model Serial No Location Parameter/Range/Units Acceptance Criteria
CAL-0333 Balance Calibration Weight 10 g Standard Weight Calibration Lab Metrology [TBD] [TBD] [TBD] Weight / 10 g / g Class F1/E2

Conditions

Environment: [TBD]

Reference Standards

Standard Name/ID Certificate No Due Date Traceability Statement
[TBD] [TBD] [TBD] ISO17025

Results

As Found Results

Test Point Measured Value (g) Pass/Fail
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

Test Point Measured Value (g) Pass/Fail
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [Pass/Fail overall]

Remarks: [TBD]

Signatures

Performed by: ______________________ Date: ___________

Checked by: ______________________ Date: ___________

Approved by: ______________________ Date: ___________

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